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All about the drug candidate arfolitixorin
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ARFOLITIXORIN

The drug candidate that can boost the effect of chemotherapy

Isofol’s folate-based drug candidate arfolitixorin ([6R]-MTHF) has the potential to be established as a key component in the treatment of CRC. Folate has long been a standard component in CRC treatment and has been proven to boost the effect of chemotherapy, but today’s folate drugs require conversion in several steps in the body before they become effective active substances. Arfolitixorin is the world’s first and only direct-acting folate-based drug candidate and thus has the potential to provide a good efficacy regardless of the patients’ ability to convert the drug.

Arfolitixorin, with its active ingredient [6R]-MTHF, is Isofol’s patented drug candidate for treating CRC.

In an early development phase comparative clinical study, Isofol demonstrated statistically that CRC patients showed at least three to four times higher levels of [6R]-MTHF in the tumor when treated with arfolitixorin compared with current folate-based treatments. When arfolitixorin was administered together with 5-FU in the treatment of CRC, the tumor-killing effect was enhanced and more cancer cells died.

Four hundred patients have been treated with arfolitixorin in clinical studies up to this point and the next step in the clinical development program for CRC is now being prepared based on a new dosage regimen that is expected to optimize the efficacy of the drug candidate.

Significant medical need

Isofol’s analyses of the market and available data for arfolitixorin indicate that there is still a significant medical need and that arfolitixorin has good potential to become a key component in the treatment of CRC. Every year, nearly two million people around the world suffer from cancer of the large or small intestine. The prognosis for patients varies depending on how early the cancer is detected. The standard treatment for CRC is based on a combination of 5-FU chemotherapy and other drugs (for example oxaliplatin, irinotecan, bevacizumab and cetuximab). To optimize the effect of chemotherapy, supplemental treatment is provided in the form of folate, a naturally occurring ingredient that is broken down in the body and converted into an active metabolite ([6R]-MHTF). This active metabolite increases the cell-killing effect of 5-FU by reducing the production of one of the building blocks that tumor cells need to reproduce. It is clear that patients with a high concentration of this active metabolite in tumor cells demonstrate significantly better treatment efficacy than those with a low concentration. However, around two thirds of patients lack the ability to produce the enzymes that are necessary to convert folate into the active metabolite. Arfolitixorin consists of this active metabolite in its pure form and the hope is that more patients will be able to benefit from the full effect of folate as a supplementary treatment through treatment with arfolitixorin.

Last updated 10-24-2024

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